This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.
It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Once daily consumption over the period of the study
Once daily consumption over the period of the study
Stoffwechselzentrum Rhein-Pfalz
Mannheim, Baden-Wurttemberg, Germany
Fasting glucose
Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.
Time frame: 6 weeks
Fasting glucose
Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.
Time frame: 12 weeks
HBA1c
long-term glucose control as measured by the concentratino of HbA1c concentration in %
Time frame: 6 weeks
HBA1c
long-term glucose control as measured by the concentratino of HbA1c concentration in %
Time frame: 12 weeks
Self-documented glucose
Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
Time frame: 6 weeks
Self-documented glucose
Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
Time frame: 12 weeks
Weight
Chenge in body Weight in kg
Time frame: 6 weeks
Weight
Chenge in body Weight in kg
Time frame: 12 weeks
BMI
Body Mass Index
Time frame: 6 weeks
BMI
Body Mass Index
Time frame: 12 weeks
Lipid metabolism: Serum triglycerides
Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)
Time frame: 6 weeks
Lipid metabolism: Serum triglycerides
Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
Time frame: 12 weeks
Lipid metabolism: apolipoprotein A (mg/dl)
Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)
Time frame: 6 weeks
Lipid metabolism: apolipoprotein A (mg/dl)
Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
Time frame: 12 weeks
Lipid metabolism: Apolipoprotein B mg/dl
Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl
Time frame: 6 weeks
Lipid metabolism: Apolipoprotein B mg/dl
Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
Time frame: 12 weeks
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
Time frame: 6 weeks
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
Time frame: 12 weeks
Lipid metabolism: HDL-cholesterol
Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl
Time frame: 6 weeks
Lipid metabolism: HDL-cholesterol
Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
Time frame: 12 weeks
Lipid metabolism: LDL- cholesterol mg/dl
Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl
Time frame: 6 weeks
Lipid metabolism: LDL- cholesterol mg/dl
Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
Time frame: 12 weeks
Microbiome
Microbiome in faeces samples at 6 weeks
Time frame: 6 weeks
Microbiome
Microbiome in faeces samples at 12 weeks
Time frame: 12 weeks
Inflammation: Il-6
Markers of inflammation at 6 weeks IL-6 in ng/ml
Time frame: 6 weeks
Inflammation: hsCRP
Markers of inflammation at 6 weeks hsCRP mg/l
Time frame: 6 weeks
Inflammation: Il-6
Markers of inflammation at 12 weeks IL-6 in ng/ml
Time frame: 12 weeks
Inflammation: hsCRP
Markers of inflammation at 12 weeks hsCRP mg/l
Time frame: 12 weeks
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